اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CLAFORAN از شرکت SANOFI AVENTIS US
Abbreviated New Drug Application (ANDA): 062659
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLAFORAN | CEFOTAXIME SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| CLAFORAN | CEFOTAXIME SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/13/1987 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/28/2010 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 11/02/2015 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 10/31/2008 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 11/01/2005 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 11/01/2005 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 06/18/2002 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/01/2001 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/13/2001 | SUPPL-29 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/19/2001 | SUPPL-28 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/07/2001 | SUPPL-27 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/08/2000 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/09/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1998 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 12/20/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/14/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/31/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/31/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/09/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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